Last updated: February 24, 2026
What is NDC 55513-0810?
The National Drug Code (NDC) 55513-0810 corresponds to a specific pharmaceutical product. Based on publicly available databases, NDC 55513-0810 is identified as Baxdela (delafloxacin) oral suspension. It is an antibiotic used for treating bacterial infections, particularly acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Market Overview
The antibiotic market for bacterial infections is mature, with significant competition from generic formulations and several branded products. The recent approval or availability of Baxdela (delafloxacin) has generated interest due to its novel mechanism targeting bacterial DNA gyrase and topoisomerase IV.
Market Size and Growth Drivers
- Current Market Size: The global antibiotics market was valued at approximately USD 47 billion in 2022 (Grand View Research). The segment for quinolones, which includes delafloxacin, accounts for roughly USD 4 billion of this figure.
- Growth Rate: Compound annual growth rate (CAGR) estimates for antibiotics are approximately 3-4% through 2030, driven by rising antimicrobial resistance and demand for new agents.
Competitive Landscape
- Key competitors: Ciprofloxacin, levofloxacin, moxifloxacin, and omadacycline.
- Differentiating factors: Baxdela offers intravenous and oral formulations, with activity against resistant strains, including methicillin-resistant Staphylococcus aureus (MRSA).
- Market share potential: Given its targeted indications and resistance profile, Baxdela could capture 5-10% of the quinolone segment in the next 3-5 years, translating to USD 200-400 million annually.
Pricing and Reimbursement Environment
- Pricing benchmarks: Branded quinolones typically retail between USD 50-100 per dose for hospital use and USD 30-70 for outpatient prescriptions.
- Baxdela price points: Currently, the wholesale acquisition cost (WAC) for Baxdela oral is approximately USD 160 per tablet (per 450 mg), higher than generic counterparts due to patent protections.
- Reimbursement: Covered by major payers including Medicare, Medicaid, and private insurers. Value-based pricing may influence net prices as competition intensifies.
Price Projections
| Year |
Estimated Wholesale Price (USD) per Course |
Key Factors |
| 2023 |
160–180 |
Launch phase, patent protection intact |
| 2024 |
150–170 |
Entry of generics, price erosion begins |
| 2025 |
130–155 |
Increasing generic competition |
| 2026 |
120–140 |
Broader generic availability |
| 2027 |
100–130 |
Price stabilization, market penetration |
Note: These projections assume steady market adoption, no major regulatory changes, and continued resistance challenges.
Regulatory and Patent Landscape
- Patent status: Baxdela’s patent protections are valid until 2030, with some extensions possible.
- Regulatory trends: FDA approval pathways favorance for antibiotics targeting resistant bacteria. Future approvals for related conditions could expand market potential.
Key Risks
- Generic entry: Sharp price reductions once patents expire.
- Resistance development: Emergence of resistance could diminish clinical utility.
- Pricing pressures: Payers push for cost-effective alternatives.
Implications for Stakeholders
- Pharmaceutical companies: Focus on market penetration before patent expiry, explore combination therapies.
- Investors: Watch for patent expiry timelines and competitive entry as catalysts for price erosion.
- Healthcare providers: Preference for cost-effective, broad-spectrum antibiotics may limit Baxdela use over time.
Key Takeaways
- NDC 55513-0810, Baxdela, is positioned within a competitive, growing antibiotic market.
- Current pricing is around USD 160 per dose; prices are expected to decline with generic competition.
- Market size could reach USD 200-400 million annually in the next 3-5 years.
- Patent protection extends until 2030; price erosion may accelerate thereafter.
- Resistance and regulatory changes pose ongoing risks.
5 FAQs
1. When is Baxdela expected to face significant price erosion?
Price erosion likely begins around 2024-2025, concurrent with generic entry and market competition.
2. How does Baxdela compare to other antibiotics in the same class?
It offers activity against resistant strains and an oral formulation, providing advantages over older quinolones but at a higher price point.
3. What are the main barriers to market penetration for Baxdela?
Generic competition and prescriber preference for established, lower-cost antibiotics.
4. How might resistance impact Baxdela’s market?
Emergence of resistant bacterial strains could limit efficacy, reducing demand and sales.
5. Are there upcoming regulatory changes that could affect Baxdela?
Future approvals for related indications and label expansions are possible but are not imminent.
References
- Grand View Research. (2023). Antibiotics Market Size & Trends.
- U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Patent Status.
- IQVIA. (2022). Prescription Drug Market Data.
- Managed Markets News. (2023). Antibiotics Pricing and Reimbursement.
- Bloomberg. (2022). Pharmaceutical Market Outlooks.
